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The Pilot Phase

Hypothesis

The pilot phase is aimed at establishing the feasibility of the project, the adherence to the protocol and the enrollment rate

Objective

The main objective of the pilot phase is to enroll 430 patients in 5 months in at least 25 Core and Vanguard centers, with a predicted enrollment rate of approximately 1 patient/center/week. This pilot phase will be carried out without external funding and using the research infrastructure of the participating centers. The results of the pilot phase will be used to apply to health care agencies in the US, Canada, and in the EU asking for support to extend the network of participating centers and to complete the follow-up.

A consent rate of > 50% of eligible patients, an enrollment rate of 80% of the predicted, a rate of compliance with the protocol > 90%, and loss to follow-up of less than 1% will be considered as a demonstration of feasibility.

In an initial pilot phase, the study will enroll 10% of the sample size (430 patients) in 25 Core and Vanguard Centers.